DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a CON of 17/781930, which is a 371 of application PCT/RU2020/50333 (filed 19 December 2020) and claims priority to foreign application RU2019141759 (filed 13 December 2019). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, because no certified translation of the foreign priority document was provided, the foreign priority claim has not been perfected. Therefore, for the purposes of searching the prior art, the effective filing date of instant claims 1-3 is 19 November 2020.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
In claim 1, lines 5-6, “Bacterial” should not be capitalized;
In claim 1, line 10, “Titer” should not be capitalized;
In claim 3, lines 5-6, “Bacteria” and “Bacterial” should not be capitalized; and
In claim 3, line 10, “Titer” should not be capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 3 each recite “a biopreparation on the basis of Bacillus mojavensis PS17”. The phrase “on the basis of Bacillus mojavensis PS17” is not defined by the claims or the specification; therefore, it is unclear what scope of biopreparations is encompassed by the claims (i.e., is the composition required to contain whole, living B. mojavensis PS17, or can it contain inactivated B. mojavensis PS17 or its components, or can the composition comprise bacteria similar to B. mojavensis PS17 or bacteria with similar properties?). In the interest of compact prosecution, “a biopreparation on the basis of Bacillus mojavensis PS17” is interpreted as a composition comprising B. mojavensis PS17 cells.
Claims 1 and 3 recite the phrase “processing the inoculated medium within a shaking machine under a temperature of 37°C”. As written, it is unclear if the temperature (i.e., a temperature of less than 37°C) refers to the temperature of the medium or the temperature of the inside of the shaking machine. In the interest of compact prosecution, both interpretations are being treated as encompassed by the claim.
Regarding claims 1 and 3, the claims recite the limitation "consumption rate.” This term renders the claim indefinite because the term is not defined by the claims or the instant specification and is vague and indefinite. Additionally, claims 1 and 3 recite different units for “consumption rate.” Thus, the claim is indefinite because one of ordinary skill in the art cannot determine the scope of the parameter of consumption rate of the claimed composition.
Claim 2 recites the limitation, “step (d) is provided twice during a paniculation stage and a blooming stage of growing.” As written, it is unclear if step (d) is performed twice during each stage or if step (d) is performed a total of two times, once during the paniculation phase and once during the blooming stage. In the interest of compact prosecution, both of these interpretations are considered to be encompassed by the claim.
Clarification is requested.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that Bacillus mojavensis PS17 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Bacillus mojavensis PS17 strain.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The instant specification teaches that the strain Bacillus mojavensis PS17 was isolated from the seed of the Sadokat variety of spring wheat (para. 10). However, the specification does not provide a method of identifying the claimed strain from all of the possible organisms that may be isolated from that source. Thus, one of ordinary skill in the art cannot obtain the claimed strain and perform the claimed method without access to the B. mojavensis PS17 strain.
It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Claims 1-3 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of improving control of plant diseases comprising administering the claimed biopreparation, does not reasonably provide enablement for methods of improving control of plant diseases in which the biopreparation is merely provided and not actually administered to the target plant population. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The focus of the enablement inquiry is whether everything within the scope of the claim(s) is/are enabled, at the time of filing, without requiring undue experimentation to make or use the invention. The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims: With respect to claim breadth, the standard under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. The claims are drawn to methods for improving control of plant diseases in wheat or potatoes and increasing efficiency of treatment of agricultural crops of wheat or increasing crop yield of potatoes.
Claim 1 recites the step “providing a treatment of the crops with said biopreparation” and claim 3 recites the step “providing a treatment of the potato tubers prior to planting thereof with said biopreparation.” The act of “providing a treatment” does not require that the treatment actually be administered to the target plant population. See MPEP 2106.04(d)(2) (“For example, a step of ‘prescribing a topical steroid to a patient with eczema’ is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a ‘pharmaceutical composition’ or that a ‘feed dispenser is operable to dispense a mineral supplement’ are not affirmative limitations because they are merely indicating how the claimed invention might be used.”). Therefore, the broadest reasonable interpretation of the claim is that the claimed biopreparation is able to improve control of leaf diseases and increase efficiency of treatment (for claim 1) or improve control of potato diseases and increase crop yield of potatoes (for claim 3) without actually being administered to the plant.
Claim 2 recites, “step (d) is provided twice during a paniculation stage and a blooming stage of growing of the summer wheat.” This claim also does not require that the biopreparation be administered to the wheat, only that it is “provided twice.”
The state of the prior art and the level of predictability in the art: Bacon and Hilton (2002, Biological Control; herein “Bacon”) teaches the use of different B. mojavensis strains to treat corn and beans to prevent infection by the fungus Fusarium moniliforme (abstract). The plants were treated by placing the bacterial inoculum on seeds prior to planting (pg. 277, left col., para. 1). Bacon teaches that all of the plants treated with B. mojavensis were symptomless and their growth was either comparable or exceeded the growth of non-treated control plants (pg. 279, right col., para. 3 and Figs. 2-3). There is no teaching in the art indicating that B. mojavensis, including strain PS17, may be used to improve control of disease, increase efficiency of treatment, or increase crop yield without being administered to crops.
Based on the prior art, one of ordinary skill in the art would not be able to predict that a B. mojavensis PS17 biopreparation is capable of improving disease control, improving treatment efficiency, and/or increasing crop yield without being administered to the target crop(s).
The amount of direction provided by the inventor and the existence of working examples: The instant specification teaches that summer wheat was treated twice (i.e., the composition was administered to the wheat), during paniculation stage and blooming stage of wheat (para. 30) and “using double treatment during crop growing period of endophytic bacteria Bacillus mojavensis PS17 with consumption rate of 1 L/ha causes prominent effect on decrease of attack by main diseases on spring wheat crops and results in growth of yield.” (para. 35) The specification also teaches that potato tubers were treated (i.e., the composition was administered to the tubers) immediately before planting (para. 36) and the B. mojavensis PS17 preparation increased efficiency of control of disease and increased crop yield (para. 38-39). The specification does not teach a method in which control of disease is improved, treatment efficiency is increased, and/or crop yield is increased when the B. mojavensis PS17 composition is not administered to the target crop.
Therefore, what is enabled by the instant specification and working examples is narrow in comparison to the scope of the claims, and the specification does not provide enough information with which one may overcome the known unpredictability in the art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004)). The instant specification is not enabling for the claimed invention because one cannot follow the guidance presented therein, or within the art at the time of filing, and perform the claimed method without first making a substantial inventive contribution.
Based on the teachings of the prior art and the instant specification, one of ordinary skill in the art would not be able to achieve the claimed functions of improving control of leaf diseases and increasing efficiency of treatment of agricultural crops or improving control of potato diseases and increasing crop yield using the claimed method in which a treatment of the crops is “provided” and not actually administered to the crops.
Therefore, claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to meet the enablement requirement.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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